Omnigrip, Latex Surgical Glove, Powder Free

K984064 is the FDA 510(k) clearance record for OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE, a class I device, cleared for Omni Intl., Inc. on 1999-01-08 under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list 12 510(k) clearances for Omni Intl., Inc., from 1982-03-08 to 1999-01-13. As of 2026-09-10, FDA records show no recalls naming K984064.